KCT0003529进行中（未招募）未知
A randomized, multicenter, open-label, phase III trial comparing anthracyclines followed by taxane versus anthracyclines followed by taxane plus carboplatin as (neo)adjuvant therapy in patients with triple-negative breast cancer
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 878
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- Female
入选标准
- •1) Female patients must be =19 years of age
- •2) ECOG 0 or 1
- •3) Histologically confirmed invasive primary breast cancer
- •4) Triple negative breast cancer: ER negative, PR negative, HER2 negative
- •- ER and PR neative definedas IHC nuclear staining < 1%
- •- HER2 negative defined as:
- •? ¦ IHC 0, 1+ without ISH OR
- •? ¦ IHC 2+ and ISH non-amplified (average HER2 gene copy number < 4 signals/cell using single-probe ISH or HER2/CEP17 ratio < 2.0 and average HER2 gene copy number < 4 signals/cell in dual-probe ISH) OR
- •? ¦ ISH non-amplified without IHC
- •5) All of the following staging criteria (AJCC[American Joint Committee on Cancer] 7th edition) must be met:
- •- Neoadjuvant group
- •? ¦ Lymph node positive breast cancer regardless of tumor size (cT1-4N1-3)
- •: Lymph node positive is defined as cytologically or pathologically confirmed lymph node metastasis by needle aspiration or core biopsy
- •? ¦ Lymph node negative breast cancer with primary tumor size > 2cm by radiographical or clinical measurement (cT2-4N0)
- •: Inflammatory breast cancer (cT4d) would be excluded.
- •- Adjuvant group
- •? ¦ Lymph node positive breast cancer regardless of tumor size (cT1-4N1-3), N1mi is considered as pN1 and N0i+ is considered as pN0. Patient with pT1N1mi (stage IB) would be excluded.
- •? ¦ Lymph node negative breast cancer with primary tumor size > 2cm by radiographical or clinical measurement (pT2-4N0)
- •: Inflammatory breast cancer (T4d) would be excluded. Patient with pT4 could be eligible only if the radiation therapy is planned.
- •6) In adjuvant group, completed adequate breast and axilla surgery defined as:
- •- The inked margins of breast conservation surgery or mastectomy must be histologically free of invasive breast cancer and ductal carcinoma in situ.
- •- The patient must have completed one of the procedures for evaluation of pathologic nodal status listed below.
- •? ¦ Axillary Lymph Node Dissection (ALND) with or without sentinel lymph node biopsy (SLNB)
- •? ¦ SLNB alone: If pathologic nodal staging based on sentinel lymphadenectomy is pN0 or if all of the followings are fullfiled:
- •? ? 1 or 2 positive nodes
- •?? Breast conserving surgery
- •?? Planned breast radiotherapy
- •7) Radomization must be performed no longer than 8 weeks from definitive surgery in adjuvant group
- •8) Patient must have adequate organ function measured within 7days prior to AC chemotherapy as defined below
- •- Marrow function
- •? ¦ Hemoglobin: = 10.0 g/dl
- •? ¦ ANC: = 1,500 / µl
- •? ¦ Platelet: = 10 × 104/ µl
- •- Kidney function
- •? ¦ Creatinine: = 1.5 x Upper Normal Limit (UNL) or
- •? ¦ Creatinine clearance (Ccr) = 50 ml/min by Cockroft formula
- •- Liver function
- •? ¦ Total Bilirubin: = 1.5 × UNL
- •? ¦ AST/ALT: = 2.5 × UNL
- •9) Patients is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination
排除标准
- •1) Any previous history of invasive breast cancer
- •2) Any prior systemic therapy (chemotherapy, endocrine therapy, targeted therapy) for cancer, including breast cancer
- •3) Any local treatment for breast cancer, though patients with curatively treated DCIS or LCIS by surgery are allowed.
- •4) Inflammatory breast cancer
- •5) Simultaneous bilateral breast cancer
- •6) Occult breast cancer
- •7) Definitive clinical or radiological evidence of metastatic disease
- •8) Patients with second primary cancers within 5 years from randomization; Exceptions: adequately treated non-melanoma skin cancer, curatively treated cervix in situ cancer, DCIS or LCIS of the breast, thyroid cancer with a size of < 2 cm (follicular, papillary, and medullary cancer), and other solid tumors curatively treated with no evidence of disease for > 5 years prior to randomization
- •9) Patients with known active Hepatitis B or C, or HIV. In healthy HBV carriers, a serology test or HBV DNA test performed based on the guidelines of each institute must confirm that it is not active hepatitis.
- •10) Pregnant or breastfeeding women
- •11) Known hypersensitivity to any of the study drugs or excipients
- •12) Peripheral neuropathy grade = 2 by NCI-CTCAE v4.03
- •13) Severe cardiopulmonary dysfunction, uncontrolled infection, or serious illness or medical conditions
- •14) Patients who are not adequate for this trial by investigator’s judgement
研究者
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